FDA Commissioner Marty Makary, MD, MPH, made expanding over-the-counter (OTC) availability of more drugs a clear priority during an April 1, 2026 press conference. “When I look at the reasons those drugs were not approved in the past, I think we can do better,” he said.
Makary specifically called out the current requirement for every OTC pill to include a study proving people can read the instructions and take it correctly. “It’s just not common sense,” he stated. Instead, he wants the agency to reduce onerous requirements and focus on safety and labeling.
The commissioner also highlighted key benefits of moving suitable drugs to OTC status, noting that it “enables better access to medication, can reduce unnecessary healthcare utilization like waiting in an urgent care facility or emergency department to get a refill,” and encourages price competition.
A recent national survey underscores the everyday role of OTC medications: 62.3% of U.S. adults reported using at least one prescription or OTC medication in the past seven days, with OTC use (46%) nearly identical to prescription use (46.3%). Six of the top 10 most-used medications were available over the counter.